Tin Filter Calcium Scoring

July 31, 2018 updated by: Medical University of South Carolina

Ultra Low-dose Coronary Artery Calcium Scoring Using Tin Filtration With Dual-source CT

The aim of this study is to prospectively investigate the diagnostic performance and potential radiation dose reduction in coronary artery calcium scoring using the new tin filter system of the 3rd generation DSCT scanner.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must be between 19-90 years of age.
  • Subject must have been referred for a clinically indicated coronary artery calcium scan and/or coronary CT angiography or TRO scan with coronary artery calcium scoring.
  • Subject must provide written informed consent prior to any study-related procedures being performed.
  • Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

  • Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
  • By testing (urine BHCG) within 24 hours before scan, or
  • By surgical sterilization, or
  • Post menopausal, with minimum one (1) year history without menses.
  • Subject has an acute psychiatric disorder or is cognitively impaired.
  • Subject is using or is dependent on substances of abuse.
  • Subject is unwilling to comply with the requirements of the protocol.
  • Subject is in acute unstable condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reduction of radiation dose and diagnostic accuracy
Reduction of radiation dose during coronary artery calcium scoring with the use of a tin filter system.
Device: Tin Filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in radiation dose using the new tin-filter system
Time Frame: 2 years
2 years
Diagnostic accuracy of novel ultralow-dose non-enhanced coronary artery calcium scoring performed with the new tin filter system.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Joseph U. Schoepf, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

November 14, 2017

Study Completion (Actual)

November 14, 2017

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00051523

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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